The U.S. Food and Drug Administration (
The FDA is requiring all pancreatic enzyme replacement therapies currently on the market to be reformulated and undergo clinical testing in order to receive approval. The Cystic Fibrosis Foundation encouraged the FDA to mandate this NDA process to ensure that all pancreatic enzyme products are of the highest quality. Unapproved products will ultimately be removed from the market, helping to ensure that CF patients receive only products that are documented to be both safe and effective.
Companies currently completing clinical trials for NDA submission to the FDA include Axcan Pharma (Ultrase®), DCI (PANCRECARB®), Eurand (Zentase™) and McNeil (Pancrease MT).